Protocol Development - Is this Medical Test Really Necessary?

Regardless if you are reading this from a sponsor, site, monitor or IRB perspective, we have all worked on a protocol with a medical test that really seems unnecessary or obsolete, not to mention, difficult to obtain with in the time window specified by the protocol.

Some of these notable tests or measurements (think repeated height measurement during follow-up visits for an adult study) are carried forward from older studies where they were providing the sponsor with pertinent information. Other tests or measurements are based on entrenched medical practices in clinical settings.

Perhaps medical device sponsors should take a look at some of these recommendations during the protocol development process. A couple that may be of interest to the medical device clinical research landscape:

Clinically noted over-used tests can be wasteful and put patients in danger without any added benefits. Similarly, in clinical research, unnecessary tests could deter the subject’s likelihood to participate in the trial, create unwanted protocol deviations, and cause unneeded stress or discomfort to the subject during participation.

Can you recall a test or measurement from a protocol that you worked on that seemed over-the-top, wasteful, unnecessary, or commonly not obtained resulting in numerous non-compliances? Do you think that protocol developers should consult more frequently with clinical standards when writing protocols?